Overview
As a Clinical Research Associate, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities
What will you be doing?
- Managing multiple oncology trials with a focus on quality of life, including regional travel.
- Demonstrating leadership through involvement in initiatives and acting as a subject matter expert (SME) in systems and processes.
- Mentoring and coaching junior team members.
- Leading training for Study Managers (SMs) on studies.
- Developing site start-up documents, including SIV agendas.
- Reviewing study documents from the SM perspective (e.g., Monitoring Guidelines).
- Representing Lead Trial Managers (LTMs) or SMs in meetings.
- Taking over LTM report reviews for sites assigned to other SMs within the same trial.
- Supporting country budget development and contract negotiations in collaboration with CCS colleagues.
- Assisting with site visit activities (ASV).
- Monitoring metrics and KPIs as outlined in the Quality Oversight Plan (QOP).
Interfaces – Primary/Other:
- Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team.
- Other: Study Physician, Regional Quality & Compliance, Local Drug Safety, Site Managers, Investigators, and site staff.
Qualifications
You Are:
- Holding a B.S., R.N., or equivalent degree, preferably in Biological Sciences.
- Located near a major airport in the Northeast region.
- Having 2-3 years’ experience in monitoring pharmaceutical clinical trials.
- Having 1-3 years' experience specifically in oncology trials.
- Knowledgeable in multiple therapeutic areas.
- Possessing analytical/risk-based monitoring experience is advantageous.
- Capable of actively driving patient recruitment strategies.
- Skilled in collaborating with investigators and site staff to meet study timelines.
- Proficient in systems like CTMS, EDC, eTMF, dashboards, IWRS, and safety reporting.
- Excellent communicator with strong influencing skills, capable of managing sites remotely and face-to-face.
- Well-versed in Good Clinical Practice, ICH guidelines, and local regulations.
- Willing to travel up to 50%.
- Legally authorized to work in the United States without future sponsorship needs.
What ICON Can Offer You
We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include:
- Various annual leave entitlements.
- Health insurance options for you and your family.
- Retirement planning benefits.
- Global Employee Assistance Programme with 24/7 support.
- Life assurance.
- Flexible country-specific benefits like childcare vouchers, gym discounts, and travel passes.
Learn more about working at ICON: https://careers.iconplc.com/benefits
We are committed to inclusion and providing a workplace free of discrimination. If you need accommodations during the application process, please let us know.
Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we're looking for!